Fistula in AnoNCT04588701
Long Term Outcomes After Surgery for Anal Fistula
An observational study of Fistula in Ano, run by University of Michigan.
Trial summary
Anal fistula is a common condition with a wide variety of clinical presentations, which can make evaluation and treatment challenging and surgical outcomes uncertain. This study was undertaken to identify lessons learned in the surgical treatment of 483 patients over a 20- year period leading to a pragmatic approach… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- surgical procedures commonly done for anal fistula
- Type of treatment
- Surgery or procedure
- How many people
- 483 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 1996to 17 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all persons with anal fistulas treated by a single surgeon at the University of Michigan Hospital from January 1996 through December 2018
Who may be able to join
- anal fistulas
Who cannot join
- none
About this study
Anal fistula is a common condition with a wide variety of clinical presentations, which can make evaluation and treatment challenging and surgical outcomes uncertain. This study was undertaken to identify lessons learned in the surgical treatment of 483 patients over a 20- year period leading to a pragmatic approach to treatment of this condition.
Read the detailed description
The wide array of variations of anal fistulas makes them challenging both to classify and to treat. The aim of the study is to determine if a systematic approach to their evaluation and surgical treatment, regardless of how one wishes to classify them, can be based on careful assessment of sphincter length and of the anatomical and etiological characteristics of the fistula.
- Conditions
- Fistula in Ano
- Being tested
- surgical procedures commonly done for anal fistula
- Keywords
- anal fistula, fistulotomy, ano-rectal advancement flap, sphincter saving
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical procedures commonly done for anal fistulaProcedure or surgery
Surgical procedures performed, including fistulotomy; fistulotomy with sphincter repair; seton; advancement flap; fistula plug;
| Study group | Role | What they receive |
|---|---|---|
| persons with anal fistulas | all persons with anal fistulas treated by a single surgeon over 22 years Receives: Procedure: surgical procedures commonly done for anal fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who heal after simple or staged operations for fistula
Measured: typically 1 year, but up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start11 Jan 1996
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula in AnoStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Burney, University of Michigan
- Investigators
- Richard E Burney, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588701
- Sponsor's protocol ID
- HUM00168195
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes After Surgery for Anal Fistula
- ClinicalTrials.gov ID
- NCT04588701
- Acronym / sponsor ID
- HUM00168195
- Conditions
- Fistula in Ano
- Keywords
- anal fistula, fistulotomy, ano-rectal advancement flap, sphincter saving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 11 Jan 1996 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anal fistula is a common condition with a wide variety of clinical presentations, which can make evaluation and treatment challenging and surgical outcomes uncertain. This study was undertaken to identify lessons learned in the surgical treatment of 483 patients over a 20- year period leading to a pragmatic approach to treatment of this condition.
Detailed description
The wide array of variations of anal fistulas makes them challenging both to classify and to treat. The aim of the study is to determine if a systematic approach to their evaluation and surgical treatment, regardless of how one wishes to classify them, can be based on careful assessment of sphincter length and of the anatomical and etiological characteristics of the fistula.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| persons with anal fistulas | – | Procedure: surgical procedures commonly done for anal fistulaall persons with anal fistulas treated by a single surgeon over 22 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all persons with anal fistulas treated by a single surgeon at the University of Michigan Hospital from January 1996 through December 2018
Key inclusion criteria (1 listed)
- anal fistulas
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical procedures commonly done for anal fistulaSurgical procedures performed, including fistulotomy; fistulotomy with sphincter repair; seton; advancement flap; fistula plug; | Procedure or surgery | persons with anal fistulas |
Primary outcome
Number of patients who heal after simple or staged operations for fistula
Time frame: typically 1 year, but up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard E Burney, MD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
An observational study of Fistula in Ano, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who heal after simple or staged operations for fistula (time frame: typically 1 year, but up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.